No More Open Heart

July 7, 2008 8:55:57 AM PDT

Each year, surgeons perform about 99,000 heart valve operations. Most of these are done to repair the mitral or aortic valves on the left side of the heart. Sometimes, medications can be taken or surgical repair can be done to fix heart valves, but in more severe cases, an entire replacement needs to be done. Traditional valve repairs and replacements require open heart surgery, which involves breaking the breastbone, stopping the heart and hooking patients up to a heart-lung machine. After surgery, patients spend one to three days in the intensive care unit (ICU), a week at the hospital and at least four to six weeks recovering at home before resuming normal activities. Both mechanical and biological valves can be used to replace a heart valve. Mechanical valves are usually made from materials such as plastic, carbon, or metal. Mechanical valves are strong, and they last a long time, but because blood tends to stick to mechanical valves and create blood clots, patients with these valves need to take blood thinning medications (called anticoagulants) for the rest of their lives. Cardiologists say blood thinners can be dangerous for children to take, considering how active they are.

THE MELODY VALVE: Made from the jugular vein of a cow, the Melody Transcatheter Pulmonary Valve is a biological valve, so patients do not need to take blood thinning medications. Designed to treat patients with congenital heart defects involving the pulmonary artery, the Melody valve is inserted via catheter through a patient's groin, then guided to the heart. When it's properly positioned, a balloon in the device is inflated, implanting the device. This provides a non-surgical means to replace the valve -- without the pain and recovery time of open heart surgery. Surgeons and patients have reported immediate improvement in patient health and alleviation of symptoms. Patients are able to leave the hospital 24 hours after the operation. This technique avoids the risk of bleeding and infection that can accompany open heart surgery and reduces costs associated with ICU care.

It's not yet known how long the valve will last in a patient's body, but doctors hope it will last 10 to 15 years. When and if repeat surgery is needed, surgeons can re-enter the body through the same entryway. Not all Melody valve replacements enter through the groin. In a few cases, the catheter was inserted through a vein in the patient's neck, then guided to the heart. The Melody has received Europe's CE Mark of approval and is available for distribution in Europe and Canada. It is currently undergoing U.S. Food and Drug Administration (FDA) trials at three locations in the United States.